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Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus on Background of Sulfonylurea Alone or With Metformin
Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus on Background of Sulfonylurea Alone or With Metformin

NCT03066830

CompletedPhase 3

Sponsor: Lexicon Pharmaceuticals

Conditions: Type 2 Diabetes Mellitus

Interventions: Sotagliflozin (SAR439954), Placebo, Metformin, Sulfonylurea

Countries: United States, Bulgaria, Estonia, Hungary, Poland, Romania, Slovakia, South Korea

Primary Objective: To demonstrate the superiority of Sotagliflozin 400 milligrams (mg) versus placebo on Hemoglobin A1c (HbA1c) reduction at Week 26 in participant with type 2 diabetes (T2D) who have inadequate glycemic control with a Sulfonylurea alone or in combination with Metformin. Secondary Objectives: * To compare Sotagliflozin 400 mg versus placebo based on: * Change from baseline in fasting plasma glucose (FPG). * Change from baseline in systolic blood pressure (SBP) for participants with baseline SBP ≥130 millimeter of mercury (mm Hg). * Change from baseline in SBP for all participants. * Change from baseline in body weight. * Percentage of participants with HbA1c \<6.5% and \<7.0%. * To evaluate the safety of Sotagliflozin 400 mg versus placebo throughout the 79-week trial.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion criteria :

* Participants with T2D treated with a Sulfonylurea (≥half the maximum recommended dose as per local label or maximum tolerated dose \[documented\]) as monotherapy or in combination with Metformin (≥1500 mg per day or maximum tolerated dose \[documented\]) each at a stable dose for at least 12 weeks without a dose adjustment before screening.
* Signed written informed consent.

Exclusion criteria:

* At the time of screening, age \<18 years or \< legal age of majority, whichever is greater.
* Body Mass Index (BMI) ≤20 or \>45 kilograms per meter square (kg/m\^2) at Screening.
* Hemoglobin A1c (HbA1c) \<7% or HbA1c \>10% via central lab test at screening.
* Fasting plasma glucose (FPG) \>15 mmol/L (270 mg/dL) measured by the central laboratory at screening (Visit 1), and confirmed (\>15 mmol/L \[270 mg/dL\]) by a repeat test before randomization.
* Women of childbearing potential with no effective contraceptive method.
* Treated with an antidiabetic pharmacological regimen other than a Sulfonylurea at a stable dose with or without Metformin within 12 weeks preceding the screening visit.
* Previous insulin use \>1 month (at any time, aside from treatment of gestational diabetes).
* History of prior gastric surgical procedure including gastric banding or inflammatory bowel disease within 3 years before the Screening Visit.
* History of diabetic ketoacidosis or nonketotic hyperosmolar coma within 12 weeks prior to the Screening Visit.
* History of severe hypoglycemia within 6 months prior to the Screening visit.
* Systolic blood pressure (SBP) \>180 millimeter per mercury (mmHg) or diastolic blood pressure (DBP) \>100 mmHg or history of hypertensive emergency.
* Aspartate aminotransferase and/or alanine aminotransferase: \>3 times the upper limit of the normal laboratory range (ULN).
* Total bilirubin: \>1.5 times ULN (except in case of Gilbert's syndrome).
* Use of systemic glucocorticoids (excluding topical or ophthalmic, application or inhaled forms) for more than 10 consecutive days within 90 days prior to the Screening Visit.
* Pregnancy, breastfeeding.
* Participants is unwilling to perform self-monitoring of blood glucose (SMBG), and complete the participant's diary as required per protocol.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Locations (76)
  • Litchfield Park, Arizona, United States
  • Peoria, Arizona, United States
  • Greenbrae, California, United States
  • Huntington Park, California, United States
  • Los Angeles, California, United States
  • Montclair, California, United States
  • Spring Valley, California, United States
  • Tustin, California, United States
  • Northglenn, Colorado, United States
  • Bradenton, Florida, United States
  • New Port Richey, Florida, United States
  • North Miami Beach, Florida, United States
  • Ocoee, Florida, United States
  • Orlando, Florida, United States
  • Palm Harbor, Florida, United States
  • Pembroke Pines, Florida, United States
  • Port Charlotte, Florida, United States
  • Nampa, Idaho, United States
  • Flint, Michigan, United States
  • Richfield, Minnesota, United States
  • Henderson, Nevada, United States
  • Greensboro, North Carolina, United States
  • Shelby, North Carolina, United States
  • Hatboro, Pennsylvania, United States
  • Kingsport, Tennessee, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • Burke, Virginia, United States
  • Plovdiv, Bulgaria
  • Rousse, Bulgaria
  • + 46 more on CT.gov